South Korean biopharmaceutical company Samsung Bioepis Co Ltd said on Friday that it has begun direct commercialisation of BYOOVIZ, a biosimilar to Lucentis (ranibizumab), across multiple European countries.
The company has completed the full transfer of commercial rights from Biogen Inc (Nasdaq:BIIB), making BYOOVIZ the fourth biosimilar directly commercialised by Samsung Bioepis in Europe, following EPYSQLI (eculizumab), OBODENCE (denosumab), and XBRYK (denosumab).
BYOOVIZ was first approved by the European Commission in August 2021 as a single-use vial for treating neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) and visual impairment due to choroidal neovascularisation (CNV). In November 2025, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for a pre-filled syringe (PFS) presentation, which is expected to be available in Europe in the second quarter of 2026.
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